{
  "code": "PHX",
  "deviceName": "Shoulder Prosthesis, Reverse Configuration",
  "deviceClass": "II",
  "regulationNumber": "888.3660",
  "panel": "Orthopedic",
  "definition": "Intended to be used to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint.",
  "submissionTypeId": "1",
  "submissionType": "510(k)",
  "clearances": {
    "total": 205,
    "last12Months": 20
  },
  "adverseEvents": {
    "total": 6724,
    "last12Months": 1992
  },
  "reviewDays": {
    "median": 125,
    "sampleSize": 205
  },
  "recalls": {
    "total": 67,
    "recent": [
      {
        "resNumber": "Z-2527-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Zimmer, Inc.",
        "firmAsPublished": "Zimmer, Inc.",
        "reason": "Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.",
        "initiated": "2026-05-20"
      },
      {
        "resNumber": "Z-2528-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Zimmer, Inc.",
        "firmAsPublished": "Zimmer, Inc.",
        "reason": "Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.",
        "initiated": "2026-05-20"
      },
      {
        "resNumber": "Z-2529-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Zimmer, Inc.",
        "firmAsPublished": "Zimmer, Inc.",
        "reason": "Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.",
        "initiated": "2026-05-20"
      },
      {
        "resNumber": "Z-2530-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Zimmer, Inc.",
        "firmAsPublished": "Zimmer, Inc.",
        "reason": "Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.",
        "initiated": "2026-05-20"
      },
      {
        "resNumber": "Z-2531-2026",
        "status": "Open, Classified",
        "recallClass": "Class II",
        "firm": "Zimmer, Inc.",
        "firmAsPublished": "Zimmer, Inc.",
        "reason": "Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.",
        "initiated": "2026-05-20"
      }
    ]
  },
  "recentClearances": [
    {
      "kNumber": "K260556",
      "deviceName": "Veritas Shoulder System",
      "applicant": "Restor3D",
      "company": "restor3d Inc.",
      "decisionDate": "2026-07-01",
      "dateReceived": "2026-02-19"
    },
    {
      "kNumber": "K261683",
      "deviceName": "Augment Off-Axis Instrument System",
      "applicant": "Zimmer, Inc.",
      "company": "Zimmer, Inc.",
      "decisionDate": "2026-06-16",
      "dateReceived": "2026-05-21"
    },
    {
      "kNumber": "K260102",
      "deviceName": "Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented Glenoid Shoulder System",
      "applicant": "Stryker Corporation (Tornier, Inc.)",
      "company": "Stryker Corporation (Tornier, Inc.)",
      "decisionDate": "2026-06-12",
      "dateReceived": "2026-01-13"
    },
    {
      "kNumber": "K261016",
      "deviceName": "MSS - Humeral reverse liners extension",
      "applicant": "Medacta International, SA",
      "company": "Medacta International, SA",
      "decisionDate": "2026-06-10",
      "dateReceived": "2026-03-27"
    },
    {
      "kNumber": "K253992",
      "deviceName": "Veritas Reverse Total Shoulder System",
      "applicant": "Restor3D",
      "company": "restor3d Inc.",
      "decisionDate": "2026-05-07",
      "dateReceived": "2025-12-12"
    },
    {
      "kNumber": "K252404",
      "deviceName": "Comprehensive Reverse Shoulder - HA Glenosphere Baseplates",
      "applicant": "Biomet Orthopedics",
      "company": "Biomet Orthopedics Corp.",
      "decisionDate": "2026-04-15",
      "dateReceived": "2025-07-31"
    },
    {
      "kNumber": "K260583",
      "deviceName": "Equinoxe® Shoulder System",
      "applicant": "Exactech, Inc.",
      "company": "Exactech, Inc.",
      "decisionDate": "2026-04-14",
      "dateReceived": "2026-02-20"
    },
    {
      "kNumber": "K254128",
      "deviceName": "InSet Reverse Total Shoulder System",
      "applicant": "Shoulder Innovations, Inc.",
      "company": "Shoulder Innovations, Inc.",
      "decisionDate": "2026-04-13",
      "dateReceived": "2025-12-22"
    },
    {
      "kNumber": "K253674",
      "deviceName": "Blueprint Patient-Specific Instrumentation",
      "applicant": "Stryker Corporation (Tornier, S.A.S.)",
      "company": "Stryker Corporation (Tornier, S.A.S.)",
      "decisionDate": "2026-04-03",
      "dateReceived": "2025-11-21"
    },
    {
      "kNumber": "K253624",
      "deviceName": "INHANCE™ Reverse Shoulder System",
      "applicant": "Depuy Ireland UC",
      "company": "Depuy Ireland UC",
      "decisionDate": "2026-03-11",
      "dateReceived": "2025-11-18"
    }
  ],
  "topApplicants": [
    {
      "name": "Exactech, Inc.",
      "count": 21
    },
    {
      "name": "Encore Medical L.P.",
      "count": 16
    },
    {
      "name": "Biomet Manufacturing Corp",
      "count": 13
    },
    {
      "name": "Medacta International S.A.",
      "count": 12
    },
    {
      "name": "Arthrex, Inc.",
      "count": 11
    }
  ],
  "topCompanies": [
    {
      "name": "Exactech, Inc.",
      "count": 21,
      "spellings": 1
    },
    {
      "name": "Tornier, Inc.",
      "count": 18,
      "spellings": 2
    },
    {
      "name": "Encore Medical, L.P. Dba Djo Surgical",
      "count": 16,
      "spellings": 1
    },
    {
      "name": "Biomet Manufacturing, Inc.",
      "count": 15,
      "spellings": 2
    },
    {
      "name": "Medacta International S.A.",
      "count": 12,
      "spellings": 1
    }
  ],
  "newEntrants": [
    {
      "name": "Stryker Corporation (Tornier, Inc.)",
      "since": "2026-06-12",
      "kNumber": "K260102"
    },
    {
      "name": "Medacta International, SA",
      "since": "2026-06-10",
      "kNumber": "K261016"
    },
    {
      "name": "Biomet Orthopedics Corp.",
      "since": "2026-04-15",
      "kNumber": "K252404"
    }
  ],
  "baseline": {
    "months": [
      {
        "month": "2023-01-01",
        "observed": 77,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-02-01",
        "observed": 68,
        "expectedLow": null,
        "expectedHigh": null,
        "isSufficient": false
      },
      {
        "month": "2023-03-01",
        "observed": 122,
        "expectedLow": null,
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        "isSufficient": false
      },
      {
        "month": "2023-04-01",
        "observed": 98,
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      {
        "month": "2023-05-01",
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      },
      {
        "month": "2023-06-01",
        "observed": 140,
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        "isSufficient": false
      },
      {
        "month": "2023-07-01",
        "observed": 118,
        "expectedLow": null,
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        "isSufficient": false
      },
      {
        "month": "2023-08-01",
        "observed": 101,
        "expectedLow": null,
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        "isSufficient": false
      },
      {
        "month": "2023-09-01",
        "observed": 89,
        "expectedLow": null,
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      {
        "month": "2024-01-01",
        "observed": 130,
        "expectedLow": null,
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        "isSufficient": false
      },
      {
        "month": "2024-02-01",
        "observed": 156,
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        "isSufficient": false
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      {
        "month": "2024-03-01",
        "observed": 221,
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        "isSufficient": false
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      {
        "month": "2024-04-01",
        "observed": 262,
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        "month": "2024-05-01",
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        "month": "2024-06-01",
        "observed": 185,
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        "month": "2024-07-01",
        "observed": 149,
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      {
        "month": "2024-08-01",
        "observed": 166,
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        "isSufficient": false
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        "month": "2024-09-01",
        "observed": 176,
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        "month": "2024-10-01",
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        "month": "2024-11-01",
        "observed": 156,
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        "month": "2024-12-01",
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        "isSufficient": false
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        "month": "2025-01-01",
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        "month": "2025-02-01",
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        "month": "2025-03-01",
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        "month": "2025-04-01",
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        "isSufficient": true
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        "month": "2025-05-01",
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        "month": "2025-06-01",
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        "month": "2025-07-01",
        "observed": 314,
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        "expectedHigh": 535.2286849358229,
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        "month": "2025-08-01",
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        "month": "2025-09-01",
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        "isSufficient": true
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        "month": "2025-10-01",
        "observed": 273,
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        "isSufficient": true
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        "month": "2025-11-01",
        "observed": 240,
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        "isSufficient": true
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      {
        "month": "2025-12-01",
        "observed": 278,
        "expectedLow": 144.09202292429717,
        "expectedHigh": 379.01277224440844,
        "isSufficient": true
      },
      {
        "month": "2026-01-01",
        "observed": 285,
        "expectedLow": 181.9523416043383,
        "expectedHigh": 432.38393890627697,
        "isSufficient": true
      },
      {
        "month": "2026-02-01",
        "observed": 231,
        "expectedLow": 168.6080566083719,
        "expectedHigh": 341.20275839157983,
        "isSufficient": true
      },
      {
        "month": "2026-03-01",
        "observed": 279,
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        "isSufficient": true
      }
    ],
    "sufficientMonths": 15,
    "method": "ewma_alpha_0.3_sd_2 corpus_adjusted"
  },
  "signal": {
    "summary": "PHX (Shoulder Prosthesis, Reverse Configuration) has three findings, most consequential first. 5 recalls opened in the last 12 months and not yet terminated (Class II) (Z-2527-2026, Z-2528-2026, Z-2529-2026, Z-2530-2026, Z-2531-2026). 3 first-time filers in the last 12 months, including Stryker Corporation (Tornier, Inc.) and Medacta International, SA (K260102, K261016, K252404). The code is crowded, scoring 76 of 100 — 39 companies hold a clearance here and 20 arrived in the last 12 months (PHX:crowding).",
    "severity": 75,
    "factors": [
      {
        "kind": "recall",
        "detail": "5 recalls opened in the last 12 months and not yet terminated (Class II)",
        "recordIds": [
          "Z-2527-2026",
          "Z-2528-2026",
          "Z-2529-2026",
          "Z-2530-2026",
          "Z-2531-2026"
        ],
        "severity": 75
      },
      {
        "kind": "new_entrant",
        "detail": "3 first-time filers in the last 12 months, including Stryker Corporation (Tornier, Inc.) and Medacta International, SA",
        "recordIds": [
          "K260102",
          "K261016",
          "K252404"
        ],
        "severity": 43
      },
      {
        "kind": "crowding",
        "detail": "the code is crowded, scoring 76 of 100 — 39 companies hold a clearance here and 20 arrived in the last 12 months",
        "recordIds": [
          "PHX:crowding"
        ],
        "severity": 20
      }
    ],
    "sourcesChecked": [
      "predicate ancestry",
      "recalls",
      "adverse events",
      "new entrants",
      "review time",
      "crowding"
    ]
  },
  "predicatePreview": {
    "edges": [],
    "note": "FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet."
  },
  "sources": [
    {
      "label": "classification",
      "url": "https://api.fda.gov/device/classification.json?search=product_code%3APHX"
    },
    {
      "label": "510k total",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3APHX"
    },
    {
      "label": "510k recent decisions",
      "url": "https://api.fda.gov/device/510k.json?search=product_code%3APHX"
    },
    {
      "label": "recalls",
      "url": "https://api.fda.gov/device/recall.json?search=product_code%3APHX"
    },
    {
      "label": "enforcement",
      "url": "https://api.fda.gov/device/enforcement.json?search=openfda.product_code%3APHX"
    },
    {
      "label": "adverse events total",
      "url": "https://api.fda.gov/device/event.json?search=device.device_report_product_code%3APHX"
    },
    {
      "label": "registrations",
      "url": "https://api.fda.gov/device/registrationlisting.json?search=products.product_code%3APHX"
    }
  ],
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53,
      "exportDate": "2026-08-04"
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:49:57Z",
      "ingestRun": 73,
      "exportDate": "2026-08-11"
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52,
      "exportDate": "2026-08-08"
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10,
      "exportDate": "2026-08-08"
    }
  ],
  "retrievedAt": "2026-08-11T13:51:45.752Z"
}